Preclinical and first-in-human safety studies on a novel magnetism-based haemofiltration method.
Sci Rep
; 14(1): 14077, 2024 06 18.
Article
in En
| MEDLINE
| ID: mdl-38890397
ABSTRACT
Extracorporeal haemofiltration devices that selectively remove cytokines could represent an adjunctive treatment in inflammatory diseases. One such device is the "IL-6-Sieve", wherein magnetic Anti-IL-6 Beads are introduced into an extracorporeal circuit via a Bead Adapter and then removed along with any surface-bound interleukin (IL)-6 by a Filter deployed in a Magnet, before the blood is returned to the patient. We report here on a series of animal studies, and a first-in-human study, on the safety of the IL-6-Sieve. Evaluations focused on the (a) safety of Filter and Magnet placed in an extracorporeal circuit in sheep; (b) safety of Anti-IL-6 Beads-directly infused intravenously as worst case scenario of misuse; or injected into an extracorporeal circuit using the Bead Adapter, Filter, and Magnet as intended-in sheep; (c) biodistribution of Anti-IL-6 Beads intravenously infused in mice; and (d) safety of Filter and Magnet placed in an extracorporeal circuit in healthy volunteers. No serious adverse events or significant changes in vital signs or routine laboratory parameters occurred in any of the animals or humans. Although safety of the IL-6-Sieve requires further study, these initial evaluations represent a promising start for the translation of this new blood purification modality into clinical use.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Hemofiltration
/
Interleukin-6
Limits:
Adult
/
Animals
/
Female
/
Humans
/
Male
Language:
En
Journal:
Sci Rep
Year:
2024
Document type:
Article
Affiliation country:
Países Bajos